FDA recall Z-1135-2022

Umano Medical, Inc. · Class II · device

Product

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

Reason for recall

There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, PA, AL, GA, AZ, MN, FL, WA, OK, NY, ND, AR, MO, NC, UT, TX, WI, and the countries of Australia, Ireland, and Canada.

Key facts

Status
Terminated
Initiation date
2022-04-11
Report date
2022-06-01
Termination date
2024-01-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
L'Islet, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1135-2022